ASUNIVA (Influenza vaccination)

The Clinical Trial Site at ITM is seeking volunteers for a new clinical trial entitled ASUNIVA. In this study, we will evaluate the effectiveness of a novel vaccine developed by the company Osivax against influenza infection.

• Who: Healthy volunteers between 18 and 59 years old Start: September 2025

• Duration: Between 6 and 10 months

• Study visits: 2 visits to the study center and 2 follow-up phone calls. Additional visits may be required in case of influenza symptoms.

• Compensation: Fixed compensation per study visit and follow-up phone call for your time.

Purpose of study

The influenza virus is a yearly seasonal virus that can cause mild to moderate symptoms such as fever, cough, headache, muscle and joint pain, runny nose, etc., but can – especially in people at risk – also cause severe illness with hospitalization or death as a result.

Influenza is a virus that easily spreads and vaccination is still considered the most effective way to prevent disease.

Multiple types of the influenza virus exist, and most currently available vaccines are designed to combat three or four virus types, that are selected each year by an expert panel. This means that the effectiveness of the vaccine will be reduced if the virus types that are circulating within the general population are different than the ones selected in the vaccine. The vaccine of Osivax that is investigated in this study, is however designed to prevent influenza disease irrespective of the type of virus, and therefore more widely usable.

How is the study conducted?

In order to evaluate how well the new vaccine works at preventing influenza disease, all participants will be divided in one of two groups: one group will receive the new vaccine while the other group will receive a placebo vaccine. The allocation to one of these groups is done completely random by a computerized system, and both you and the site personnel will not know to which group you belong, until after the end of the study.

When you are invited to participate, you will be screened for participation during the first visit. There are many factors that contribute to this decision, which the study doctor will review together with you. If you qualify, the vaccine will be administered the same day.

You will then be asked to return to the study site 7 days later to review your response to the vaccine.

About one month after the vaccination, you will be contacted by phone to see if you have any side-effects and to check if you have had any influenza symptoms. The same will be done between 6 and 10 months after you received the vaccination.

During the entire study you will be asked to complete any influenza symptoms into a phone application. In case your report symptoms, you will be asked to come to the study site for a swab so that we can determine the potential presence of influenza virus.

Who can participate?

For this study, we are looking for healthy volunteers between 18 and 59 years old, without chronic conditions and who didn’t receive an influenza vaccination in the past 6 months.

There are many more criteria that will be checked by the study doctor to determine if you are eligible for participation in the study. These will be reviewed together with you during the first study visit. The most important ones are listed in the subscription page (see below).

Compensation

To compensate you for your time, any expenses you incur to participate in the study, and any other inconveniences you may experience, you will receive a fixed fee per study visit and per follow-up telephone call.

If you commit to participating in the study, we strongly urge you to complete the entire study. However, please know that you can withdraw your participation at any time.

Team

• Principal Investigator: Prof Dr Patrick Soentjens (MD, PhD)

Questions?

Contact us at studies@itg.be.